Low Protein Diet in CKD Patients at Risk of Malnutrition

NCT05015647 | Completed

• 1 other identifier: 1274/2018
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

It's a pilot study with an open label randomized-controlled design. Estimated number of patients should have been 38, taking in account of a maximal drop out up to 20% of the sample. We enrolled 35 patients, 27 of whom terminated the study as per protocol (14 in the Low protein (LP) group and 13 in the Normo Protein (NP) group). Patients were treated for six months with two different dietary prescriptions:

1. 1.LP group (n=17) was prescribed high calories/low proteins diet (30 Kcal/kg and 0.6-0.7gr/kg respectively). In order to assure prescribed calorie intake, this group was supplemented with commercial protein free products (protein content \<2%).
2. 2.NP group (n=18) was prescribed high calories/normal proteins diet (30 kcal/kg and 0.8 gr/kg respectively).

Conditions

Chronic Kidney Diseases; Malnutrition

Keywords

chronic kidney disease; Malnutrition

Outcome Measures

Primary Outcomes (4)

• Change from baseline MIS at 6th month

  Malnutrition-inflammation score is a validated scoring system for the assessment of malnutrition and inflammation syndrome in patients with CKD. MIS involves the evaluation of ten different domains, each of which is categorized with 4 severity levels (score scale 0-3). A total score of 4-7 was considered indicative of mild malnutrition and a score ≥8 of severe malnourishment

  measured at baseline and 6 months.

• Change from baseline serum albumin at 6th month

  in g/dL

  measured at baseline and at 6 months.

• intergroup MIS comparison at 6 months

  Malnutrition-inflammation score is a validated scoring system for the assessment of malnutrition and inflammation syndrome in patients with CKD. MIS involves the evaluation of ten different domains, each of which is categorized with 4 severity levels (score scale 0-3). A total score of 4-7 was considered indicative of mild malnutrition and a score ≥8 of severe malnourishment

  6th month

• Intergroup comparison of the number of patients that reached a MIS ≥8 at 6 months

  Malnutrition-inflammation score is a validated scoring system for the assessment of malnutrition and inflammation syndrome in patients with CKD. MIS involves the evaluation of ten different domains, each of which is categorized with 4 severity levels (score scale 0-3). A total score of 4-7 was considered indicative of mild malnutrition and a score ≥8 of severe malnourishment

  6th month

Secondary Outcomes (16)

• Differences of GFR estimated with creatinine

  measured at baseline and at 6 months.

• Differences of GFR estimated with cystatin C

  measured at baseline and at 6 months.

• Differences in serum urea

  measured at baseline and at 6 months.

• Differences in creatinine clarance

  measured at baseline and at 6 months.

• Differences in phosphorous

  measured at baseline and at 6 months.

Study Arms (2)

LP group

EXPERIMENTAL

LP group (n=17) was prescribed high calories/low proteins diet (30 Kcal/kg and 0.6-0.7gr/kg respectively) supplemented with commercial protein free products (protein content \<2%).

Dietary Supplement: LP group

NP group

ACTIVE COMPARATOR

NP group (n=18) was prescribed high calories/normal proteins diet (30 kcal/kg and 0.8 gr/kg respectively)

Other: NP group

Interventions

LP group DIETARY_SUPPLEMENT

LP group patients replaced pasta, bread, biscuits etc. with low protein substitutes. We allowed them to consume more animal products than NP, preferring white meat to red meat and trying to limit cold cuts as much as possible. Furthermore, they were advised to prefer fresh or frozen fish, instead of dried or smoked one as well as to prefer fresh cheeses to seasoned ones. As for legumes, we advised to combine them with bread or normal cereals, for protein complementarity.

LP group

NP group OTHER

NP group was given the indication to try to eat the second dish only once a day or to split the portion of the second plate between lunch and dinner, if they wanted to keep the habit of making the meal complete. It was also given the indication to prefer, among protein sources, those of plant origin. We also indicated to alternate or replace cow's milk with plant substitutes such as: rice, almonds' or oats' drinks. Furthermore, we suggested to prefer white meat and to avoid offal and processed meat. Moreover, we indicated to substitute dried or smoked fish with fresh or frozen one.

NP group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• advanced CKD not yet on renal replacement therapy (10\< - eGFRcreat \<30 ml/min)
• age \>65 years
• at risk of malnutrition at Malnutrition Inflammation Score (4≤MIS≤7)
• spontaneous low protein-energy intake (proteins \< 0.8g/kg and energy \< 25 kcal/kg).

You may not qualify if:

• Active chronic infectious diseases
• Heart failure of severity \> NYHA2
• Active neoplastic diseases
• Inability to cooperate
• Presumed overall life expectancy \< 6 month
• Decompensated liver diseases
• Malabsorption
• Decompensated thyroid o surrenal diseases
• Refusal to participate
• Immunosuppressive and/or steroid therapy

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Unit of nephrology, dialysis and renal transplantation - Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

Location

Related Publications (27)

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  PMID: 29854979 BACKGROUND

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• Caldiroli L, Vettoretti S, Armelloni S, Mattinzoli D, Ikehata M, Molinari P, Alfieri C, Messa P, Castellano G. Possible Benefits of a Low Protein Diet in Older Patients With CKD at Risk of Malnutrition: A Pilot Randomized Controlled Trial. Front Nutr. 2022 Jan 26;8:782499. doi: 10.3389/fnut.2021.782499. eCollection 2021.

  PMID: 35198584 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Malnutrition

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Simone Vettoretti, Dr

  Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were treated for six months with two different dietary prescriptions: 1. LP group (n=17) was prescribed high calories/low proteins diet (30 Kcal/kg and 0.6-0.7gr/kg respectively). In order to assure prescribed calorie intake, this group was supplemented with commercial protein free products (protein content \<2%). 2. NP group (n=18) was prescribed high calories/normal proteins diet (30 kcal/kg and 0.8 gr/kg respectively).

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 20, 2021
• Study Start: September 26, 2018
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)